PMID- 35676941
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220716
IS  - 2352-8737 (Electronic)
IS  - 2352-8737 (Linking)
VI  - 8
IP  - 1
DP  - 2022
TI  - Integrated Alzheimer's Disease Rating Scale: Clinically meaningful change 
      estimates.
PG  - e12312
LID - 10.1002/trc2.12312 [doi]
LID - e12312
AB  - INTRODUCTION: The Integrated Alzheimer's Disease Rating Scale (iADRS) has been 
      used to detect differences in disease progression in early Alzheimer's disease 
      (AD). The objectives of this study were to enhance understanding of iADRS point 
      changes within the context of clinical trials, and to establish a minimal 
      clinically important difference (MCID) on the iADRS. METHODS: Data from AMARANTH 
      and EXPEDITION3 were analyzed using various approaches, including anchor-based, 
      distribution-based, regression analyses, and cumulative distribution function 
      (CDF) plots. Three potential anchors were examined, including the Clinical 
      Dementia Rating-Sum of Boxes, Mini-Mental State Examination, and Functional 
      Activities Questionnaire. Triangulation of all results was used to determine the 
      MCID for participants with mild cognitive impairment (MCI) due to AD and AD with 
      mild dementia. RESULTS: All three anchors met criteria for "sufficiently 
      associated" (|r| = 0.4-0.7). Cumulatively, results from anchor-based and 
      distribution-based results converged to suggest an iADRS MCID of 5 points for MCI 
      due to AD and 9 points for AD with mild dementia. Regression analyses and CDF 
      plots supported these values. DISCUSSION: These findings suggest the iADRS can be 
      used in clinical trials to detect a clinically meaningful outcome of AD 
      progression.
CI  - (c) 2022 Eli Lilly and Company. Alzheimer's & Dementia: Translational Research & 
      Clinical Interventions published by Wiley Periodicals LLC on behlaf of 
      Alzheimer's Association.
FAU - Wessels, Alette M
AU  - Wessels AM
AD  - Eli Lilly and Company Indianapolis Indiana USA.
FAU - Rentz, Dorene M
AU  - Rentz DM
AD  - Department of Neurology Massachusetts General Hospital, Harvard Medical School 
      Boston Massachusetts USA.
AD  - Center for Alzheimer Research and Treatment Department of Neurology Brigham and 
      Women's Hospital, Harvard Medical School Boston Massachusetts USA.
FAU - Case, Michael
AU  - Case M
AD  - Eli Lilly and Company Indianapolis Indiana USA.
FAU - Lauzon, Steve
AU  - Lauzon S
AD  - Eli Lilly and Company Indianapolis Indiana USA.
FAU - Sims, John R
AU  - Sims JR
AD  - Eli Lilly and Company Indianapolis Indiana USA.
LA  - eng
PT  - Journal Article
DEP - 20220606
PL  - United States
TA  - Alzheimers Dement (N Y)
JT  - Alzheimer's & dementia (New York, N. Y.)
JID - 101650118
PMC - PMC9169866
OTO - NOTNLM
OT  - Alzheimer's disease
OT  - Integrated Alzheimer's Disease Rating Scale
OT  - clinical meaningfulness
OT  - cognitive/functional composite endpoint
OT  - minimal clinically important change
OT  - minimal clinically important difference
COIS- Alette M. Wessels, Michael Case, Steve Lauzon, and John R. Sims are all employees 
      and minor shareholders at Eli Lilly and Company. Dorene M. Rentz reports 
      consulting relationships with Biogen IDEC and Digital Cognition Technologies; she 
      also serves on the Scientific Advisory Board for Neurotrack.
EDAT- 2022/06/10 06:00
MHDA- 2022/06/10 06:01
PMCR- 2022/06/06
CRDT- 2022/06/09 02:04
PHST- 2022/02/21 00:00 [received]
PHST- 2022/04/22 00:00 [revised]
PHST- 2022/05/04 00:00 [accepted]
PHST- 2022/06/09 02:04 [entrez]
PHST- 2022/06/10 06:00 [pubmed]
PHST- 2022/06/10 06:01 [medline]
PHST- 2022/06/06 00:00 [pmc-release]
AID - TRC212312 [pii]
AID - 10.1002/trc2.12312 [doi]
PST - epublish
SO  - Alzheimers Dement (N Y). 2022 Jun 6;8(1):e12312. doi: 10.1002/trc2.12312. 
      eCollection 2022.